Mobile Electrocardiogram System

ABSTRACT

An electrocardiogram (“ECG”) system is provided. The system includes an ECG device capable of receiving ECG signals from a lead system attached to the user. The ECG device then renders the ECG signals into ECG data, and transmits the ECG data to at least one of a user device, such as a smart phone, or a cloud-based storage system. The user device is capable of rendering the ECG data into an ECG graph, and displaying the ECG graph to the user on an application (“app”). The system also provides for a cloud-based storage system capable storing the ECG data and providing access to the ECG data to the user and to medical personal.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 62/638,590 filed Mar. 5, 2018, the entire disclosure ofwhich is expressly incorporated herein by reference.

BACKGROUND Technical Field

The present disclosure relates generally to the field of medicaldevices. More specifically, the present disclosure relates to a mobileElectrocardiogram (“ECG”) system and method of use.

Related Art

There are 700-750,000 heart attacks in the United States annually, ofwhich 210,000 are recurrent events. In addition, 8-10 million patientsvisit the emergency room (“ER”) annually for chest pain. Through theprocess of interviewing practicing clinicians, it is readily apparentthat there are numerous recurrent visits to the ER. These result incostly hospital stays for patients who have had myocardial infarction(“MI”). There is a push by the insurance and hospital industries toreduce these visits, as well as other “unnecessary” visits to the ER. Ofall the chest pain (“CP”) visits to the ER, only 0.06% are truelife-threatening emergencies once per prognosticator indicators havebeen accounted for.

The consequences of each CP visit to the ER are psychological, as wellas direct and indirect economic costs. Once a patient has had an acutecoronary syndrome (“ACS”) event, especially at a young age (under 65y/o), the psychological ramifications are significant. Those patientstypically live in fear of their cardiac status and the fear of havinganother myocardial infarction (“MI”). This effect also spills over totheir immediate friends, family and co-workers, some of whom may becomeworried about their own mortality. Post-MI depression occurs affects 1in 6 patients and 2 out of every 6 patients have some signs/symptoms ofdepression leading to increased mortality rates within the first 6months. According to various medical sources, up to 12% of the post-ACSpatients develop Post-Traumatic Stress Disorder (“PTSD”) which resultsin a doubling of their risk of another ACS event and mortality within1-3 years.

The economic implications of chest pain are quite significant. Table 1demonstrates the potential economic damages to the patient from anunnecessary visit to the ER:

TABLE 1 (US Government 2017, 2018 Health Plan and Prices) Typical Siteof Visit in the US Average cost per use in the US system SystemAmbulance $300 ER Co-Pay  $0-$300 Observation level stay in the$2500-$5000 hospital Loss of Wages due to ER visit or $162 - See medianincome $59,039/ hospital stay 365 days, Loundenback 2017 Visit toprimary care physician $15-$30 Visit to specialist  $30-$100

These prices are approximate depending on the patient's health plan.Many patients must meet deductibles of $2500-$6000 before theirinsurance covers the cost of an ER visit or even an observation stay inthe hospital.

Cost to Hospitals:

1. Economic loss from extended stays:

-   -   a. Hospitals are reimbursed $800-$2000 per observation stay;        therefore, any        -   stay longer than 14 hours will likely result in an economic            loss;        -   i. Unnecessary in-hospital testing will result in a loss as            well;        -   ii. ER over-crowding results in slower treatment for            patients who truly need immediate care; and        -   iii. Repeat patient visits to the ER result in heavy losses.

Societal Cost (See Appendix 2, Indirect cost projections to 2035):

-   -   1. Increasing insurance premiums/deductibles;    -   2. Loss of productivity due to sick days;    -   3. Diversion of vital resources from those who need services;        and    -   4. Contribution to rising cost of healthcare.

The goals of the US healthcare system are to reduce the cost of care,expedite care, reduce length of stay in the hospital, and reducereadmission rates while maintaining quality of care. This includesmaintaining low complication rates and improving patient satisfaction

In order to do so, hospitals across the US have been providing valueadded services at their own expense, such as telehealth services forcongestive heart failure (“CHF”) management. The current reimbursementmodel results in a very low profit margin for chest pain services. Thus,anything a hospital can do to reduce unnecessary admissions is in itsbest interest.

The unsettled and rapidly expanding space is the world of wearablestechnology provides immediate biofeedback to the wearer. By variousestimates, the mHealth (mobile health) market is poised to grow into amulti-billion dollar industry. Still in its infancy, advancements inmicro-technology, micro-processing, and software development allowinnovators to develop products which were either only dreamed about10-20 years ago or allow legacy devices to be miniaturized andrepurposed for mobile platforms. Those individuals willing to be engagedwill find a supply of products to meet many of their healthcare needs.The thrust for these devices is to liberate patients from costly tests,reduce financial burdens on the patient and healthcare system, andcreate an environment which motivates individuals to adhere to aprescribed regimen. Accordingly, these and other needs are addressed bythe mobile ECG system of the present disclosure.

SUMMARY

This present disclosure relates to a mobile ECG system and method ofuse. The system includes a portable, easy-to-use ECG device that allowsusers to record ECG data, and to transmit the ECG data to a user device.Additionally, the system provides for a cloud-based storage systemcapable storing the ECG data and providing access to the ECG data to theuser and to medical personal.

The ECG system in accordance with the present invention includes amobile ECG device designed to provide medical-quality tracings at a costaffordable to the average American. Unlike the traditional 12-lead ECG,the ECG device can be a 9-lead system which would capture the majorityof acute coronary syndromes by coupling ECG data with interactivesoftware which together would risk stratify the need for emergentmedical care. Utilizing the ability to compare serial ECGs and beingable to accurately assess changes in the ST-segment and T waves alongwith the input of symptoms and basic vital signs, the ECG system wouldcapture the majority of heart attacks as well as assisting indifferentiating cardiac from non-cardiac chest pain so that the user isable to make an educated decision on whether or not a visit to the ER iswarranted. This is accomplished by utilizing evidence-based algorithmswhich have already been incorporated into current clinical practices.

The ECG system is generally designed with simplicity in mind. For thelimb leads, either a 4-bracelet system, 1 for each wrist, and 1 for eachankle can be used. Also, the Mobile ECG system can be designed using azero-bracelet, a 2-bracelet and 3-bracelet system.

The signal processing used in the ECG system can be incorporated into achest plate housing with wireless electrocardiographic transmission to auser device, such as a smart phone, tablet or laptop. An additionaliteration of the ECG system can include a separate processing unit whichwill be connected either wirelessly or by wire. The processing unit canbe configured to transmit the electrocardiogram to the user device. Inaddition, due to the chest device, the ECG system can be configured tomonitor and/or measure the respiratory rate of the wearer.

The ECG system is configured to utilize the electrocardiographic dataand compare such data with prior electrocardiographic data and provide acomparison by analyzing such measurements from the user. In addition,the ECG system can be configured to display the respiratory rate of theuser.

The ECG device, through the utilization of modern technology, redesignsand reinvents the ECG machine to provide complete portability. The ECGis a critical component of the diagnostic portfolio, currently availableonly in the ER/hospital setting or a physician's office.

In the short term, the ECG demonstrates irreplaceability through theaccuracy of its ECG tracing and comparison capabilities and the accuracyof its risk stratification capacity through a learning interactivealgorithm. Customer retention and improvement follows through continuedhardware and software improvements. Service line expansion occurs byoffering a cheaper device with limited capabilities but enhancedsoftware for chronic disease state management.

Currently, no commercially available devices/systems address this issue.There are multiple manufacturers of single-lead ECG systems whichmonitor only basic arrhythmia and heart rate monitoring; such systemsare inadequate to assist in the differentiation of cardiac fromnon-cardiac chest pain. Home telehealth companies currently utilizeBluetooth-connected oximeters, scales, and blood pressure cuffs for CHFpatients. The information is sent to a monitoring center and requires anurse to review the data, review the information with the patient'sphysician, and then guide the patient on medication changes.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing features of the invention will be apparent from thefollowing Detailed Description of the Invention, taken in connectionwith the accompanying drawings, in which:

FIG. 1 is a diagram illustrating the electrocardiogram (“ECG”) system ofthe present disclosure;

FIG. 2 is a diagram illustrating the hardware and software components ofan ECG device of the present disclosure;

FIG. 3 is a diagram illustrating the hardware and software components ofa user device (e.g., a smart phone) in communication with the recorder;

FIG. 4 is a flowchart illustrating process steps carried out by the ECGdevice of the present disclosure;

FIG. 5 is a flowchart illustrating process steps carried out by the userdevice of the present disclosure;

FIG. 6 is a diagram showing user functions of an ECG application of thepresent disclosure;

FIG. 7 is a diagram showing system functions of the ECG system of thepresent disclosure;

FIGS. 8A-8C are photos illustrating user interface screens generated bythe user device including a home screen, a create account screen, and asign in screen;

FIG. 9 is a flowchart illustrating process steps carried out by the userdevice of the present disclosure for a physician login process;

FIG. 10 is a flowchart illustrating process steps carried out by theuser device of the present disclosure for a user login process;

FIG. 11 is a flowchart illustrating process steps carried out by theuser device of the present disclosure for a user profile update process;

FIGS. 12A-12E are photos illustrating user interface screens generatedby the user device including various profile screens as discussed inrelation to FIG. 11;

FIG. 13 is a flowchart illustrating process steps carried out by theuser device of the present disclosure for answering a healthquestionnaire;

FIGS. 14A-14B illustrate an example flow of questions and answers thatcan be asked by the health questionnaire of the present disclosure.

FIGS. 15A-15C are photos illustrating user interface screens generatedby the user device including various health questionnaire screens;

FIGS. 16A-16B are photos illustrating user interface screens generatedby the user device including various health questionnaire screens;

FIG. 17 is a flowchart illustrating process steps carried out by theuser device of the present disclosure connecting with the ECG device.

FIG. 18 is a photo illustrating a circuit board of an ECG device of thepresent disclosure;

FIG. 19 s a block diagram showing an electrical schematic of an ECGdevice of the present disclosure;

FIG. 20 is a photo of an ECG analog front end integrated circuit and anADAS1000 evaluation board of the present disclosure;

FIG. 21 is a block diagram showing an architecture of an ECG device ofthe present disclosure;

FIG. 22 is a diagram illustrating an IoT-based ECG monitoring system ofthe present disclosure; and

FIG. 23 is a diagram showing system functions of the IoT-based ECGmonitoring system of FIG. 22 of the present disclosure.

DETAILED DESCRIPTION

The present disclosure relates to a mobile Electrocardiogram (“ECG”)device and method of use, as described in detail below in connectionwith FIGS. 1-23.

FIG. 1 is a diagram illustrating a mobile ECG system, indicatedgenerally at 10. The system includes an ECG device 12, a user device 14,a network 16, lead(s) 18, and a remote server 20. The ECG device 12 is amobile device capable of capturing and transmitting ECG data obtainedfrom the one or more leads 18. The ECG data includes digital or analogsignals. The lead(s) 18 is a electrical connection connected to the ECGdevice 12 on one end, and to an electrode on the other end. Theelectrode is attached to a body part or appendage and is capable ofcapturing the ECG signals. The user device 14 can be any electronicdevice such as a mobile phone, a tablet computer, a smartphone, aphablet, an embedded device, a personal computer, a desktop computer, awearable device, a field-programmable gate array (“FPGA”), anapplication-specific integrated circuit (“ASIC”), etc. The ECG device12, the user device 14, and the leads 18 will be discussed in furtherdetail below.

The network 16 can be any type of wired or wireless network, includingbut not limited to, a legacy radio access network (“RAN”), a Long TermEvolution radio access network (“LTE-RAN”), a wireless local areanetwork (“WLAN”), such as a WiFi network, an Ethernet connection, or anyother type network. The ECG device 12 can be connected to the userdevice 14 via a wireless network connection (e.g., Bluetooth, WiFi,LTE-RAN, etc.) or a direct wired connection between the ECG device 12and the user device 14 (e.g., a wired universal serial bus (USB))connection. Optionally, mobile ECG device 12 and the user device 14could communicate with a remote server 20. The remote server 20 can beany type of server used for data storage, such as, for example, a harddrive, a cloud storage repository (e.g., Dropbox, Google Drive, etc.),etc. The remote server 20 can receive data via the network 16 from theECG device 12 and the user device 14.

FIG. 2 is a diagram illustrating components of the ECG device 12 ingreater detail. The ECG device 12 includes a processor 22, a memory 24,an input/output device 30, a WiFi transceiver 32, a Bluetoothtransceiver 34, an ECG lead port 36, and other components 38. Theprocessor 22 executes software/firmware modules for controlling the ECGdevice 12, such as a WiFi connection module, a Bluetooth connectionmodule, software/firmware for detecting electrical activity of the heart(as described in greater detail below), etc. The memory 24 can be ahardware component configured to store data related to operationsperformed by the ECG device 12. Specifically, the memory 24 can storeECG data received from the leads 18. The memory can include anysuitable, computer-readable storage medium such as a disk, non-volatilememory 26 (e.g., read-only memory (“ROM”), erasable programmable ROM(“EPROM”), electrically-erasable programmable ROM (“EEPROM”), flashmemory, etc.), volatile memory 28, (e.g., random access memory (“RAM”),dynamic random-access memory (“DRAM”), etc.) or other types of storagemedia. The input/output device 30 is a hardware component that enables auser to enter inputs and display results, such as a display,touchscreen, etc.

The WiFi transceiver 32 could include any suitable,commercially-available transceiver configured to transmit and/or receivedata via a WiFi frequency band, and which enables communication withother electronic devices directly or indirectly through a WiFi networkbased upon the operating frequency of the WiFi network. The Bluetoothtransceiver 34 could include any suitable, commercially-availabletransceiver configured to transmit and/or receive data via a Bluetoothconnection, and which enables communication with other electronicdevices directly or indirectly through a Bluetooth connection based uponthe operating frequency of the Bluetooth wireless technology standard.It be understood that the ECG device 12 can include either or both ofthe transceivers (WiFI transceiver 32 and Bluetooth transceiver 34), orany other suitable transceivers, such as, but not limited to, Zigbeetransceivers, LTE transceivers, 3G legacy transceivers, etc.

The ECG lead port 36 could include any suitable port for connecting anECG lead system to the ECG device 12. The ECG lead system includes oneor more leads 18 connected to an electrical connection clip on one end(e.g., an octopus cable), and a mean to connect to one or moreelectrodes on the other end (e.g., an alligator clip). The electricalconnection clip can be inserted into the ECG lead port 36. Eachelectrode can be placed on a patient's limbs (e.g., arms and legs), orchest. The ECG lead system can comprise any number of leads 18 producingany number of channels output. For example, the ECG lead system caninclude 10 leads producing a 12 channel output, 7 leads producing a 9channel output, which is expandable to a 12 channel output (e.g., 6 limblead output: aVR, aVL, aVF, I, II, III; chest leads: V2, V3, V4expandable to V1, V2, V3, V4, V5, V6), etc.

For limb leads, a bracelet system can be used, such as, for example,4-bracelet system, a zero-bracelet, 2-bracelet, and 3-bracelet system.The 4-bracelet system can include one lead for each wrist and one leadfor each ankle. The zero-bracelet system can be in the form of a fullywearable chest piece with all of the necessary leads incorporated into achest and abdomen plate. In this arrangement, 3-5 precordial leads canbe used in addition to an extension towards both shoulders and both hipsso as to complete the zero bracelet system. The 2-bracelet system caninclude a bracelet for each ankle and the chest piece can house 3-5precordial leads and have two extensions, one towards each shoulder forthe remaining limb leads. The 3-bracelet system can include a chestpiece with 3-5 precordial leads and an extension lead towards either theright or left shoulder along with one bracelet for either the right orleft wrist and one bracelet for each ankle. The chest piece can includechest patches which include adjustable components for body sizing andlocation placement.

Alternatively, the electrodes can each comprise wireless functionalitywhere each electrode transmits ECG data wirelessly to the ECG device 12or the user device 14. For example, each electrode, bracelet and chestpiece can comprise a processor and/or a wireless transceiver (e.g.,Bluetooth transceiver, WiFi transceiver, etc.) or transmitter totransmit the ECG data to a transceiver in the ECG device 12 or in theuser device 14.

The other components 38 can be a battery, wireless charging device, apower port/cable, an audio output device, an audio input device, a dataacquisition device, a USB port, one or more further ports toelectronically connect to other electronic devices, a respirometer bodytemperature sensor, an oxygen sensor, a blood pressure sensor, a globalpositioning system (“GPS”) device, a movement/motion accelerometer, abody weight/fat sensor, etc.

By way of example, the ECG device 12 can include a chest patch with awire extension toward a left shoulder and from the left shoulder to aright shoulder, another wire extension from a chest patch towards a lefthip and from the left hip towards a right hip. The ECG device 12 canconnect to the chest patch. By way of another example, the ECG device 12can be incorporated into a wearable clothing item or othersleeve/accessory design with integrated sensors and transmitters withadjustments for different body sizing.

FIG. 3 is a diagram illustrating the user device 14 in greater detail.As discussed above, the user device can be a portable device such as asmartphone, a laptop, a tablet, etc., or a stationary device such as adesktop terminal. The user device 14 includes a processor 42, a memory44, an ECG application 46 which is stored in the memory 44 and executedby the processor 42, a display device 48, an input/output device 50, acellular transceiver 52, a WiFi transceiver 54, a Bluetooth transceiver56, and other components 58. The processor 42 can be configured toexecute one or more applications of the user device 14. For example, theapplications can include a web browser, the ECG application 46, etc. Thememory 44 can be a hardware component configured to store data relatedto operations performed by the ECG device 12. For example, the memory 44can store data received from the ECG device 12. The memory can includeany suitable, computer-readable storage medium such as a disk,non-volatile memory (e.g., read-only memory (“ROM”), erasableprogrammable ROM (“EPROM”), electrically-erasable programmable ROM(“EEPROM”), flash memory, etc.), volatile memory, (e.g., random accessmemory (“RAM”), dynamic random-access memory (“DRAM”), etc.) or othertypes of storage media.

The ECG application 46 is a software application (“app”) that cancommunicate with the user device 14 via, for example, a Bluetooth or aWiFi wireless connection. The ECG application 46 can also perform otherfunctions, such as initiate a connection pairing, receive user inputs,transmit the user inputs to the ECG device 12, receive data from the ECGdevice 12, manage the data, change parameters of the ECG device 12 orthe ECG application 46, show an electrocardiogram received from the ECGdevice 12, receive ECG data from a third party, etc. Additionally, theECG application can store data collections, surveys, psychologicalstates, recommended diets/exercises, patient diets/exercises,medications, medical histories, symptoms, activities, lifestyles,recommend proper leads/sensor placements, etc. These functions will beexplained in greater detail below. The ECG application 46 can havesecurity features for ensuring HIPPA compliance, including dataencryption and user identity.

The display device 48 can be a hardware component configured to showdata to a user. The input/output device 50 can be a hardware componentthat enables the user to enter inputs. The display device 48 and theinput/output device can be separate components or integrated together,such as a touchscreen.

The cellular transceiver 52 is a hardware component configured totransmit and/or receive data via a cellular connection. Specifically,the cellular transceiver 52 enables communication with other electronicdevices directly or indirectly through a cellular network (e.g., an LTEnetwork, a legacy network, etc.) based upon the operating frequency ofthe cellular network.

The WiFi transceiver 54 could include any suitable,commercially-available transceiver configured to transmit and/or receivedata via a WiFi frequency band, and which enables communication withother electronic devices directly or indirectly through a WiFi networkbased upon the operating frequency of the WiFi network. The Bluetoothtransceiver 56 could include any suitable, commercially-availabletransceiver configured to transmit and/or receive data via a Bluetoothconnection, and which enables communication with other electronicdevices directly or indirectly through a Bluetooth connection based uponthe operating frequency of the Bluetooth wireless technology standard.

The other components 58 can include a battery, an audio output device,an audio input device, a data acquisition device, one or more ports toelectronically connect to other electronic devices, etc. The processsteps of the invention disclosed herein could be embodied ascomputer-readable software/firmware code executed by the user device 14,and could be programmed using any suitable programming languagesincluding, but not limited to, C, C++, C#, Java, Python or any othersuitable language without departing from the spirit or scope of thepresent disclosure.

FIG. 4 is a flowchart illustrating process steps carried out by the ECGdevice 12 of the present disclosure, indicated generally at 70. In step72, the ECG system 12 receives ECG data from a user (e.g., a patient).As discussed above, the ECG system 12 can be connected to the user viathe ECG lead system. In step 74, the ECG system 12 records the ECG dataonto the memory 24. The ECG data can be stored as raw data, renderedinto any suitable format that can be used for storage, transmission,compression, identification, viewing, or other purposes. In step 76, theECG device 12 transmits the ECG data to the user device 14. For example,if the user device 14 is paired to the ECG device 12 via a Bluetoothconnection or a WiFi connection, the ECG device 12 can transmit thestored data to the user device 14 on the appropriate channel or band asoutlined by the protocols of the wireless connection. It should be notedthat the user device 14 can also render the ECG data into any suitableformat.

If the ECG device 12 is not connected to or paired with the user device14, the ECG device 12 can store the ECG data until a connection or apairing is performed with the user device 14. In another example, theECG device 12 can transmit the ECG data to the remote server 20. In step78, after the ECG data has been transmitted to the user device 14 or theremote server 20, the ECG device 12 can delete the ECG data from thememory 24. Alternatively, the ECG device 12 can maintain the ECG data inthe non-volatile memory 26 until a user input or predetermined conditionoccurs. The predetermined condition can include reaching a storagecapacity threshold value, exceeding a time duration, etc.

FIG. 5 is a flowchart illustrating additional process steps carried outby the user device 14 of the present disclosure, indicated generally at80. In step 82, the user device 14 pairs with the ECG device 12. Asdiscussed above, the user device 14 can pair with the ECG device 12 viaa via a wired or other wireless connection (e.g., Bluetooth or a WiFiconnection). In step 84, the user device 14 receives a user input. In afirst example, the user input is a request for the ECG data from the ECGdevice 12. In a second example, the user input is a change in one ormore parameters/settings relating to the mobile ECG device 12 or the ECGapplication 46. The parameters/settings can relate to data collectionprocesses, a registration process, profile information, display options,security options (e.g., passwords, PINs, etc.) a questionnaire, WiFinetwork options/identifications/passwords, an IP address, remote serveroptions (e.g., storage destination, account settings, etc.), memorystorage size (e.g., a maximum size for storing on the non-volatilememory 26, volatile memory 28, and/or the memory 44), etc. Otherexamples of the parameters/settings can include options such as allowingthe ECG device 12 to use a cellular network of the user device 14 toupload the ECG data to the remote server 20, changing setting related tothe Bluetooth connection or the WiFi connection, transferring the ECGdata to a further device, etc. In step 86, the user device 14 processesthe user input. For example, if the user input includes the userrequesting ECG date from the ECG device 12, the user device 14 cantransmit a signal instructing the ECG device 12 to transmit any storedECG data to the user device 14.

FIG. 6 is a diagram showing various user functions of the ECGapplication 46, indicated generally at 100. A user 102 can be a generaluser or a healthcare provider (e.g., a physician), each of which willhave different application functionalities available. The general usercan interact with the ECG application 46, and perform actions such ascapture ECG signals, register, create/update a profile, submit aquestionnaire, etc. These functions will be explained in greater detailbelow. The general user may or may not be a patient. The healthcareprovider can be a doctor or a physician who is mapped to one or moregeneral users. The healthcare provider can perform actions such asreviewing mapped general users historical data, responding to a generaluser's questionnaire, reviewing ECG data, and performing actions similarto those available to the general user.

In function 104, the user 102 can perform a new user/patient/physicianregistration. In an example, the registration process can require anemail account, a social security number, a national provideridentification (“NPI”) number, a physician identification number(“UPIN”), etc. In function 106, the user 102 can perform a physicianlogin. For example, the physician login can require a username/password, a UPIN, etc. In function 108, the user 102 can update apatient profile. For example, the user 102 can update general profileinformation (address, height/weight, etc.) a user health history,general health details, etc.

In function 110, the ECG application 46 displays ECG data and providessearching and filtering capabilities. Specifically, in function 122, theuser 102 can view previous ECG data from a selected date/time. Infunction 124, the user 102 can search/filter ECG signal data. Infunction 126, the user 102 can view (display) a current ECG waveform. Infunction 128, the user 102 can compare ECG data/waveforms from differentreadings.

In function 112, the user 102 can complete a patient questionnaire Infunction 114, the user 102 can perform ECG signal capture function andinternet-of-thing (“IoT”) device integration. Specifically, the user 102can connect the ECG application 46 with the ECG device 12 (via, forexample, a Bluetooth connection) and receive data from the ECG device12. More specifically, in function 130, the user 102 can perform a newECG data capture, comprising, receiving ECG signals/data from the ECGdevice (function 132), extracting key metrics from the signals/data(function 134), generating calculated values (function 136), storing theECG signals/data (function 138), and correlating the ECG signals/data(function 140). Additionally, the ECG application 46 can further allowphysicians to locate patients, view ECG data authorized by the patients,and provide comments on the patients' ECG data.

FIG. 7 is a diagram showing system functions of the system 10, indicatedgenerally at 150. Specifically, the system 10 can provide a role-basedaccess control function 152, a capture ECG signals/data function 154, agenerate ECG waveforms function 156, a simulate ECG signals for multipleruns function 158, an ECG signal analysis function 160, an IoT cloudintegration function 162, and an IoT device (e.g., the ECG device 14)integration function 164. The capture ECG signals/data function 154includes a simulate ECG signals function 170, a correlate ECG signalsfunction 172, an ECG signal data extraction function 174, a generatecalculated values function 176, and a store ECG values function 178.

The ECG signal analysis function 160 includes a generated waveform for aselected date function 182, a historical signal data analysis function184, a search and filter ECG data runs function 186, and an analyzecaptured signal data (live) function 188. The IoT cloud integrationfunction 162 includes a create IoT hub on a cloud computing platform(e.g., Microsoft Azure) function 192, a send ECG signals to IoT hubfunction 194, and a send key ECG analytics to IoT hub function 196. TheIoT device integration function 164 includes an integrate with IoTdevice function 202, a generate calculated values function 204, areceive ECG signals from IoT device function 206, and an extract ECGmetrics from IoT device function 208.

FIGS. 8A-8C illustrate user interface screens of the ECG application 46,according to the present disclosure. Specifically, FIG. 8A shows theuser prompted with a create/sign in screen. In a first example, the usercan select a “Create” button 212 to generate a newuser/patient/physician registration using function 104. In anotherexample, the user can select the “Sign in” button 214 to sign into thepatient or physician account. FIG. 8B shows the user prompted with acreate screen used to create an account. The user will enter their fullname, an email address, a password, select whether they're a physician,and then select the “Create your account” button 216. If the user is aphysician, the user may further be prompted to enter verification data,such as an NPI number. FIG. 8C shows a sign in screen used by a user tosign into their account. Once the user is logged into the ECGapplication 46, the functions of the ECG application 46 will beaccessible to the user. In an example, the physician can update his/herprofile, search for a patient, view a patient's ECG sessions, update orcomment on a patient's ECG session, etc. In another example, theuser/patient can update their profile, fill out a health questionnaire,start an ECG session, view past ECG sessions, share data with aphysician, etc.

FIG. 9 is a flowchart illustrating process steps for a physician loginprocess carried out by the ECG application 46 of the present disclosure,indicated generally at 250. In step 252, the physician attempts to loginto the ECG application 46 by entering required information (e.g., username, password, etc.). In step 254, the system determines whether thelogin attempt is successful. If successful, in step 256, the physicianrequests patient authorization or requests to see patient records (e.g.,ECG data). In step 258, the system determines whether the physician hasauthorization to view the patient records. If the physician is notauthorized, in step 260, the system will prompt the physician with anaccess denied message. If the physician is authorized, in step 262, thesystem will determine which patient related features the physician isauthorized to access. In an example, the patient related featuresinclude viewing a patient's ECG data, find a patient by name or otheridentifying information, display a list of patients with their ECG data,display ECG data with a waveform, provide comments on the ECG data,review patient questionnaires, etc.

FIG. 10 is a flowchart illustrating process steps for a user loginprocess carried out by the ECG application 46 of the present disclosure,indicated generally at 270. In step 272, the user attempts to log intothe ECG application 46 by entering required information (e.g., username, password, etc.). In step 274, the system determines whether thelogin attempt is successful. If successful, in step 276, the user ispresented prompted with buttons representing various functions, such as,a health questionnaire button 276, a profile update button 278, and astart ECG capture button 280. It should be understood that otherfunctions and buttons, including any discussed within the presentdisclosure, can also be prompted to the user. When the user selects oneof the buttons, the system, in step 282, determines whether the functionof the selected button can be submitted (e.g., execute). If an erroroccurs during submission, in step 284, the user device 14 displays anerror message. If the submission is successful, in step 286, the systemupdates the local storage (e.g., memory 24) and/or a cloud computingplatform (e.g., Azure). In step 288, the system determines whether theupdate was successful. If the update is successful, in step 290, theuser device 14 displays an update successful message. If the update isunsuccessful, in step 292, the user device 14 displays an updateunsuccessful or error message.

FIG. 11 is a flowchart illustrating process steps for a user profileupdate process carried out by the ECG application 46 of the presentdisclosure, indicated generally at 300. In step 302, the user attemptsto log into the ECG application 46 by entering required information(e.g., user name, password, etc.). In step 304, the system 10 determineswhether the required information (credentials) are valid. If thecredentials are invalid, the system 10 returns to step 302. If thecredentials are valid, the system 10 proceeds to step 306, where theuser device 14 displays to the user one or more buttons, including theupdate profile button. In step 306, the user selects the update profilebutton by, for example touching the button on a touchpad of asmartphone, and update information in the profile. The information caninclude, for example, personal details, contact details, a medicalhistory, etc. Further, the user can add a physician, which would allowthe physician to view the user's records, history, ECG data, etc. Instep 308, the user confirms the changes by selecting an update button.If the update is successfully, in step 310, the user device 14 displaysa successful update message. If the update is unsuccessfully, in step312, the user device 14, displays an unsuccessful update or message.

FIGS. 12A-12E illustrate example user interface screens of the ECGapplication 46, according to the present disclosure. Specifically, FIGS.12A-12E show various profile screens as discussed above in relation toFIG. 11. More specifically, FIG. 12A shows a profile interface where theuser can select functions, such as view profile, ECG settings,notifications (turn on/off), add a physician, logout, and view versiondata. FIG. 12B shows the profile interface where the user can enterbasic information, such as a name, email address, password, homeaddress, phone number, and gender. FIG. 12C shows the profile interfacewhere the user can view his/her previously entered basic information.FIG. 12D shows the profile interface where the user can enter detailinformation, such as whether the user is a diabetic, a clinic name, amedical history, physical details, and whether the user had any majorsurgeries. FIG. 12E shows the profile interface where the user can viewhis/her previously entered detail information.

FIG. 13 is a flowchart illustrating process steps for answering a healthquestionnaire, carried out by the ECG application 46 of the presentdisclosure, indicated generally at 320. In step 322, the system 10examines the user's authorization. For example, the system 10 maydetermine whether pre-conditions exist that would prevent the user fromanswering the questionnaire. The pre-conditions can include profiledetails being fully updated, the user assigning an appropriate role thattallows the user access to submit the health questionnaire (e.g., theuser registered as a patient, not a physician), etc. In step 324, thesystem determines whether the user is authorized to answer thequestionnaire. If the user in unauthorized, in step 326, the user device14 displays an error message. If the user is authorized, in step 328,the user device 14 displays the questionnaire for user input. Once thequestions are answered by the user, in step 330, the user selects asubmit button. If the submission is unsuccessful, the system proceeds tostep 332, where the user device 14 displays an error message. Asubmission can be unsuccessful when, for example, a questionnaire hasbeen previously submitted. In such a case, the user can view thequestionnaire in a read-only mode and can modify the answers byselecting a “Edit” button. If the submission is successful, the systemproceeds to step 334, where the user device 14 displays a successfulsubmission message. In step 336, the system stores the responses on thememory 24 and/or a cloud computing platform. In step 338, the systemdetermines whether the system 10 stored or updated the responses. If anerror occurred, in step 332, user device 14 displays an error message.If the system 10 stored or updated the responses successfully, the userdevice 14 proceeds to step 340, where the user device 14 displays asuccessful update message. FIGS. 14A and 14B show an example flow ofquestions and answers that can be asked by the questionnaire (carriedout by the steps of 320 of FIG. 13).

FIGS. 15A-15C illustrate example user interface screen of the ECGapplication 46, according to the present disclosure. Specifically, FIGS.15A-15C show various questionnaire screens as discussed above inrelation to FIG. 13. More specifically, FIG. 15A shows a first page of ahealth questionnaire, which asks the user if he/she is in pain, and, ifyes, what are the pain's characteristics (following by a plurality ofchoices to answer the question). FIG. 15B shows a second page of thehealth questionnaire, which asks the user if the pain is relieved by oneor more of a plurality of selectable answers, or if the pain is madeworse by one or more of a plurality of selectable answers. FIG. 15Cshows a third page of the health questionnaire, which asks the user ifhe/she has any other symptoms of discomfort, followed by a plurality ofselectable answers,

FIGS. 16A-16C illustrate user interface screen of an ECG capture,according to the present disclosure. Specifically, FIG. 16A shows theuser is prompted with an ECG screen including a recent record button 352(showing one ECG recording from Sep. 12, 2018) and a “Live ECG Capture”button 354. Selecting the recent record button 352 will displaypreviously recorded ECG data or an ECG graph. It should be understoodthat the ECG recording from Sep. 12, 2018 is shown by way of example,and multiple ECG recordings from multiple dates and multiple timesduring a single date can be shown. Further, the user can filter ECGrecordings by selecting specific or ranges of dates and times. The ECGrecordings (and data) can be received and stored by the ECG application46 from the ECG device 12, the server 20, a further device, anelectronic transfer (e.g., air drop, text, email, Bluetooth connection,etc.), or from any other device or method.

Selecting the “Live ECG Capture” button 354 will display the screenshown in FIG. 16B. Specifically, FIG. 16B shows a live ECG graph (e.g.,ECG signals in a wave form using a time series line chart) beinggenerated from data received from the ECG device 12. Specifically, theECG application 46 can receive single or multiple analog or digitalsignals from the ECG device 12, which are consolidated from multiplesensors (e.g., leads 18). It is noted that the user is connected to theECG device 12 via the leads 18. The signal(s) can include raw data,consolidated data, formatted data, compressed data, converted data(e.g., ECG data plotted into a waveform), etc. Upon selection of the“Live ECG Capture” button 354, the ECG signals can be captured,transmitted and/or recorded immediately by the ECG device 12, after apredetermined delay, and/or for a predetermined duration, referred tohereafter as parameters. In a first example, the ECG signals can becaptured between 5-25 seconds after selection of the button 354. In asecond example, the ECG signals can be capture between 0-25 secondsafter selection of the button 354, where the first 5 seconds are storedbut not used for generating a waveform. The parameters can be set to anyvalues by the user, a physician, a technician, etc., and can relate toindustry standards or error mitigation techniques. As discussed above,the ECG data, ECG graph, or any other data generated from the ECG datacan be stored on the ECG device 12, the user device 14, or the server20.

FIG. 17 is a flowchart illustrating process steps for connecting withthe ECG device 12, carried out by the ECG application 46 of the presentdisclosure, indicated generally at 370. In step 372, the user logs intothe ECG application 46. In step 374, the system 10 determines whetherthe login was successful. If successful, in step 376, the ECGapplication 46 determines the status of the ECG device 12. In step 378,the ECG application 46 determines whether the ECG device 12 is inworking condition. If the ECG device is not in working condition, instep 380, the system 10 transmits a signal to recalibrate the ECG device12. If the ECG device 12 is in working condition, in step 382, the ECGapplication 46 determines whether the ECG device 12 and the user device14 are synced via a Bluetooth connection (or any other wired or wirelessconnection). If the ECG device 12 and the user device 14 are synced, instep 384, the system 10 determines whether the ECG device 12 isgenerating ECG signals (digital and/or analog). If the ECG device 12 isgenerating ECG signals, in step 386, the system 10 determines whetherthe ECG signals are streaming over the Bluetooth connection. If the ECGsignals are streaming over the Bluetooth connection, in step 388, thesystem 10 determines whether the ECG signals are being captured by theuser device 14. If the ECG signals are captured by the user device 14,in step 390, the system 10 stores the ECG signals on the memory 44and/or on the server 20. In step 392, the system 10 determines whetherthe ECG signals have been successfully stored. If the ECG signals havenot been successfully stored (e.g., server unreachable, memory full,etc.), in step 394, the system 10 displays an error message on the userdevice 14. If the ECG signals have been successfully stored, in step396, the system 10 displays an success message on the user device 14.

In an example, the ECG device 12 can connect directly to the network 16via a LTE or WiFi connection, and comprise the ECG application 46. Aswould be understood by those skilled in the art, the ECG device 12 wouldbe capable of performing the methods and function discussed above withregards to the user device 12. Thus, a need to pair the ECG device 12 tothe user device 14 would be eliminated, as the ECG device 12 can performthe all of the combined functions of the ECG device 12 and the userdevice 14.

The system 10, via any or any combination of ECG device 12, the userdevice 14, and the server 20 can identify possible issues through ascoring algorithm or a risk score, such as, a low/medium/high risk orlikelihood of having a cardiac condition, or other conditions.Additionally, critical values measured by the system 10 can be marked aslow/medium/high risk. This can allow a user to determine whether to seekurgent medical attention. The scoring algorithms/risk scores can includea score involving platelet glycoprotein IIb/IIIa in unstable anginareceptor suppression using Intergrilin (eptifibatide) therapy, athrombolysis in myocardial infarction score, a global registry of acutecoronary events score, a fast revascularization in instability incoronary disease score, a score related to heart history, ECG, age, riskfactors and troponin, or any other suitable algorithm or risk score.

The system 10 can further provide advanced analytics and businessintelligence solutions. For example, the system 10 can provide avisualization of data and information through dashboards, graphs,charts, visual key performance indicators (“KPI”), trends, etc. Further,the system can provide a cognitive and artificial intelligence platformcapable of creating advanced machine learning algorithms to detect andidentify trends, issues, predictions regarding the user's health status,utilizing proprietary and public domain algorithms (e.g., a stable chestpain assessment algorithm) with continuous learning capabilities, etc.The data and information can be stored in the server 20 or in the userdevice 14, and can be shared with medical personal, including, forexample, hospitals, doctors, administrators, nurses, insurance agencies,etc. For example, a user can transmit the data and information to adoctor prior or during a checkup appointment.

FIG. 18 is a photo illustrating a circuit board of an ECG device 400.The ECG device 400 includes an ECG lead port 402, a pair of processors404 a and 404 b, a Bluetooth transceiver 406, a battery pack 408, andother components. The ECG device 400 can connect to the user device 14via a Bluetooth connection, and to a patient via an ECG lead systeminserted into the ECG lead port 402.

FIG. 19 is a block diagram 420 of the ECG device of the presentdisclosure. It should be understood that the block diagram 420 is by wayof example. The block diagram 420 includes a power switch 422, a battery424, a DC/DC converter (3.3 V out) 426, a Bluetooth LED connectivityindicator 428, a push button 430, a microcontroller 432, a debuggingcommunication port 434, an ECG analog front end integrated circuit 436,input filters 438, and an ECG connector 440.

FIG. 20 is a photo of an ECG analog front end integrated circuit and anADAS1000 evaluation board. The integrated circuit includes fiveacquisition ECG channels and one driven lead, can chain additionalintegrated circuits for 10+ channels, supports lead-off detection,internal pace detection, respiration detection via two electrodes, andincludes a standard comm interface to microcontroller.

FIG. 21 is a block diagram 450 showing an architecture of an ECG deviceof the present disclosure. It should be understood that the blockdiagram 450 is by way of example. The master integrated circuit(ADAS1000) 452 can support six leads (four limbs+V1 and V2). The masterintegrated circuit 454 is connected to a slave integrated circuit 454 tosupport up to 12 leads (including V3, V4, V5, V5, Spare).

FIG. 22 is a diagram illustrating an IoT-based ECG monitoring system inaccordance with the present disclosure, indicated generally at 470. Thesystem includes an ECG sensing network 472, the IoT cloud platform 474,and the graphical user interface 476. The ECG system 470 establishes abridge between the digital world (e.g., the internet) and the real word(e.g., a physical device, such as the user device 14, where physicaldevices are connected to a cloud platform and create a uniqueidentification over the Internet in the cloud platform. The ECG sensingnetwork 472 includes an ECG sensor 482 connected via a wirelessconnection (e.g., a Bluetooth connection) to a network capable device484, which is connected via a wireless connection (e.g., a WiFiconnection) to the IoT cloud 474. The ECG sensor 482 can be the lead 18,the ECG device 12, or any other ECG sensor device. The network capabledevice 484 can be the ECG device 12, the user device 14, or any otherdevice capable of connecting to the Internet.

The IoT cloud 474 platform includes data storage system 492, a dataanalysis system 494, a disease warning system 496, and a data cleaningsystem 498. The data storage system 492 can be any type of storagesystem, including, but not limited to the server 20. For example, thedata storage 492 can include a Cosmos database, which is acost-effective service that stores the data that IoT devices send to thecloud. The database stores large meter data and supports flexible dataformat to derive insights, and follows semi-structured model to easilycombine various device types having differing data schemes.

The data analytics system 494 can be any type of analytics system, suchas those discussed in the present disclosure regarding analyzing ECGdata. For example, the data analysis system 494 can include use areal-time analytics service, such as Stream Analytics, to help in thedetection of anomalies and retrieval of archived data from smartmeters/devices. The analytics service allows to write stream processinglogic in a language similar to SQL from the data derived from theconnected devices and forwards the extracted results to the event hub, abusiness analytics service (e.g., Power BI) and table storage services

The disease warning system 496 can be any type of system to warn a useror medical professional of a disease risk to the user (e.g., alow/medium/high risk or likelihood of having a cardiac condition, etc.)The data cleaning system 498 can be any type of system to detect andcorrect (or remove) corrupt or inaccurate records from a record set, atable, a dataset, etc. The IoT cloud 474 can communicate wirelessly withmedical professionals 500 or with the graphical user interface 476,which includes a mobile app 502 (e.g., ECG application 46 or any othermobile app) and the Internet 504 (e.g., a website, a web app, etc.). Theweb apps and mobile apps, part of app service, help in hosting a webapplication used for configuring and sending commands to devices (e.g.,the ECG device 12, the user device 14, the leads 18,), inspecting thedata dashboard, creating or updating business logic and perform severalevents-driven functions.

It is noted that the IoT-based ECG monitoring system 470 can becategorized into six layers, which include smart device and controllers(e.g., ECG sensors), connectivity and protocol communication, an IoThub, a cloud server, data storage and accumulation, data analysis andcomputing, and user applications and report generation. The IoT hub is akey component of any IoT solution. It primarily serves as a cloudgateway that connects all the ECG devices with the cloud and establishescommunication between them. It can scale to connect millions of metersand can process huge volumes of data. It supports multiple protocolssuch as http, AMPG, MQTT to enable control and command capabilities. Itis also responsible for per-device authentication, thus playing a majorrole in security aspects. The IoT hub also provides secure communicationbetween ECG and user devices, and the cloud platform. Other systems thatcan be used include a message broker, used to connect systems andreceive messages, and a rules engine(s), which can processes messagesand provide an intergration mechanism with other services/systems, suchas the databases.

The IoT-based ECG monitoring system 470 can include an event hub, whichhandles millions of events every second to stream the events intovarious applications. Variable load profiles like connected devices,mobile apps, application performance counters generate telemetry dataperiodically and/or in real time. The event hub consumes these events toaccommodate numerous load profiles and process massive amounts of data

The IoT-based ECG monitoring system 470 can further enabletransformation of collected data into intelligence using, for example, amachine learning system (e.g., Azure ML, etc.). The machine learningsystem offers limitless scalability, availability and unmatchedsecurity. Also, the machine learning system generates powerful insightsfor real-time and predictive analytics, helps in fixing resilient &persistent issues, and makes reliable predictions, which can help theutility operations team and the consumers to become aware of utilityusage.

FIG. 22 is a diagram showing system functions of the IoT-based ECGmonitoring system 470, indicated generally at 520. The user device 522can receive data (e.g., ECG data) from the ECG device 524, andcommunicate with an active directory system 526, which can provide aplatform with enhanced security, access management, scalability andreliability for connecting users with applications. In function 528, thesystem 470 receives data from devices (e.g., the user device 522), andtransmits the data an IoT hub REST API(s) 530. Next, the system 470transmits the data to a cloud gateway 532, which can dump raw data 534onto a storage server 536, and calculate ECG params over the raw ECGdata 538. The ECG params can be transmitted to a SQL database 540. Inaddition, the SQL database 540 can communicate directly with the userdevice 522. The system can further transmit data from the SQL databaseto a business analytic service 542 (e.g., PowerBI), which can transmitprocessed data to a web or mobile application 544 for display.

The following additional analysis information is provided to furtherhighlight the benefits and advantages of the ECG system of the presentdisclosure.

Political:

The political climate has been dictating cheaper and faster care with areduction in cost, length of stay, and readmissions. Medical carespending comprises nearly 18% of the US GDP.

The Affordable Care Act (ACA) continues to be an economic burden and maybecome unsustainable. Recent projections by the Congressional BudgetOffice expect the majority of individuals enrolled in an insuranceprogram to be those in the Medicaid pool, whereas private insuranceenrollments will decrease. This raises a concern as to thesustainability of the ACA. Current politicians are looking to amend theACA in order to reduce costs and provide a modified bill which meets theshort-term and long-term needs of the American people withoutbankrupting the country.

Economic:

According to the Institute for New Economic Thinking, the ACA's expensesare skewed such that the sickest 10% of the patients utilize nearly ⅔ ofevery healthcare dollar. The cost per person (of the sickest patient) isapproximately 54,000/yr. The remaining 90% of the patients cost anaverage of 6000/yr.

The ECG system offers a low cost solution to help reduce the number ofER visits for all chest pain patients, and especially those who have hada prior cardiac issue.

Societal:

At a biomedical level, the ECG system offers data very similar to atraditional 12-lead ECG. However, correlation through clinical trials isneeded to validate the data. Society's challenge is accepting proof ofconcept that a system capable of learning symptoms, risk factors,physical exam, and ECG data provides feedback as an adjunct to that of aclinician.

Other societal benefits come from fewer days lost from work and lessstress on patient support systems such as friends/family.

Societal challenge: clinical risk through poor performance

-   -   Mitigate by rigorous clinical quality control.    -   Chest pain lasting more than 10 min, with typical symptoms will        instruct the patient to call Emergency Services.

Technological:

As with any mobile health platform, cybersecurity and patient privacyare of concern.

The data obtained from each patient must be scrutinized carefully as itwill be a skewed/biased population based on disease state or diseaseconcern. Improvements in algorithmic assessments should be based onscientifically validated and accepted data.

Currently, the European Union and the Food and Drug Administration (FDA)are actively working on policies and procedures to regulate new mobilehealth technology. Currently the FDA grants device approvals via a510(k) pathway. This pathway allows new technology to prove equivalenceto pre-existing technology.

Environmental:

By reducing patient visits to the ER, with a downstream effect ofreducing admissions, there will be a reduction in energy consumption aswell as waste. The ECG system not only has a direct impact on theenvironment, but the long term effect of a cleaner environment is ahealthier community.

T-M-O Analysis:

As a new player in the wearables market, the ECG system's niche forexploitation is the diagnostic algorithm space integrated with riskstratification to assist in the triage process.

Currently, the only ECG monitoring devices available for mobile use aresingle-lead systems for the lay person which are able to evaluate heartrhythms and 2-3-lead systems which are intended for physicians toprescribe for use on patients for the purpose of arrhythmia detection.

Today, a 9-lead system with an app designed to help providetriage-related advice does not exist. The ECG system, at this time, isthe initial company in this segment of the wearables market, therebygiving it a first mover advantage.

Early competitors include Cardionet, LifeWatch®, Cardiostaff, Medtronic,and AMI-cardiac monitoring. All of these systems are 2-3-channel systemsand monitor for arrhythmias only with the exception of LifeWatch® whichperforms ST segment monitoring as well. Qardio and Omron arrhythmiamonitors are designed for the layperson coupled with a mobile app andare single lead systems only. The Omron system is not a wearable

Having thus described the system and method in detail, it is to beunderstood that the foregoing description is not intended to limit thespirit or scope thereof. It will be understood that the embodiments ofthe present disclosure described herein are merely exemplary and that aperson skilled in the art may make any variations and modificationwithout departing from the spirit and scope of the disclosure. All suchvariations and modifications, including those discussed above, areintended to be included within the scope of the disclosure. What isintended to be protected by Letters Patent is set forth in the followingclaims.

What is claimed is:
 1. A mobile electrocardiogram (“ECG”) device,comprising: a processor; a transceiver in communication with theprocessor; a memory in communication with the processor; and a leadsystem connected to a user; the processor receiving ECG signals from thelead system, recording the ECG data onto the memory, transforming theECG signals into ECG data, and transmitting the ECG data, via thetransceiver, to at least one of a user device or a cloud-based storagesystem.
 2. The ECG device of claim 1, wherein the transceiver is one ofa cellular transceiver, a Bluetooth transceiver or a WiFi transceiver.3. The ECG device of claim 1, wherein the lead system comprises 7 leadsproducing a 9 channel output.
 4. The ECG device of claim 3, wherein thelead system is expandable to a 12 channel output.
 5. The ECG device ofclaim 1, wherein the lead system comprises 10 leads producing a 12channel output.
 6. The ECG device of claim 1, wherein the lead systemtransmits the ECG signals to the ECG device via a wireless connection.7. The ECG device of claim 1, wherein the lead system comprises a chestpatch, a first wrist bracelet, a second wrist bracelet, a first anklebracelet, and a second ankle bracelet.
 8. The ECG device of claim 7,wherein the ECG device is attachable to the chest patch.
 9. The ECGdevice of claim 1, wherein the processor transmits the ECG data inresponse to a request from the user device.
 10. A method for recordingelectrocardiogram (“ECG”) data from a user, comprising the steps of:receiving, via an ECG device, ECG signals from a lead system; recordingthe ECG signals onto a memory of the ECG device; transforming the ECGsignals into ECG data, and transmitting the ECG data, via a transceiverof the ECG device, to at least one of a user device or a cloud-basedstorage system.
 11. The method of claim 10, wherein the transceiver isone of a cellular transceiver, a Bluetooth transceiver or a WiFitransceiver.
 12. The method of claim 10, wherein the lead systemcomprises 7 leads producing a 9 channel output.
 13. The method of claim12, wherein the lead system is expandable to a 12 channel output. 14.The method of claim 10, wherein the lead system comprises 10 leadsproducing a 12 channel output.
 15. The method of claim 10, wherein theECG device receives the ECG signals from the lead system via a wirelessconnection.
 16. The method of claim 10, wherein the lead systemcomprises a chest patch, a first wrist bracelet, a second wristbracelet, a first ankle bracelet, and a second ankle bracelet.
 17. Themethod of claim 10, wherein step of transmitting the ECG data is inresponse to a request from the user device.
 18. A method for recordingelectrocardiogram (“ECG”) data; comprising the steps of: attaching alead system to a user, wherein the lead system is in communication withan ECG device; generating a graphical user interface on a user device tobe displayed to the user; wherein the user device is in a wirelesscommunication with the ECG device; selecting on the graphical userinterface a function to record ECG signals from the user; transmitting asignal from the user device to the ECG device, wherein the signalinstructs the ECG device to record the ECG signals from the user;recording the ECG signals from the user via the ECG device;transmitting, via the ECG device, the ECG signals or ECG data convertedfrom the ECG signals to the user device; displaying an ECG graphgenerated from the ECG signals or the ECG data to the user on the userdevice.
 19. The method of claim 18, further comprising; receiving arequest for access to the ECG data from a further user; grantingpermission for access to the ECG data to the further user; andtransmitting the ECG data to the further user.
 20. The method of claim18, wherein the lead system is in communication with the ECG device viaa wireless connection.